Relationships between symptoms and lung function in asthma and/or chronic obstructive pulmonary disease in a real-life setting: the NOVEL observational longiTudinal studY.

BACKGROUND: The relationships between spirometric assessment of lung function and symptoms (including exacerbations) in patients with asthma and/or chronic obstructive pulmonary disease (COPD) in a real-life setting are uncertain. OBJECTIVES: To assess the relationships between baseline post-bronchodilator (post-BD) spirometry measures of lung function and symptoms and exacerbations in patients with a physician-assigned diagnosis of asthma and/or COPD. DESIGN: The NOVEL observational longiTudinal studY (NOVELTY) is a global, prospective, 3-year observational study. METHODS: Logistic regression analysis was used to evaluate relationships. Spirometry measures were assessed as percent predicted (%pred). Symptoms were assessed at baseline, and exacerbations were assessed at baseline and Year 1. RESULTS: A total of 11,181 patients in NOVELTY had spirometry data (asthma, n = 5903; COPD, n = 3881; asthma + COPD, n = 1397). A 10% lower post-BD %pred forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) - adjusted for age and sex - were significantly associated with dyspnea (modified Medical Research Council ⩾ grade 2), frequent breathlessness [St George's Respiratory Questionnaire (SGRQ)], frequent wheeze attacks (SGRQ), nocturnal awakening (Respiratory Symptoms Questionnaire; ⩾1 night/week), and frequent productive cough (SGRQ). Lower post-BD %pred FEV1 and, to a lesser extent, lower post-BD %pred FVC were significantly associated with ⩾1 physician-reported exacerbation at baseline or Year 1. This association was stronger in patients with COPD than in those with asthma. CONCLUSION: In a real-life setting, reduced lung function is consistently associated with symptoms in patients with asthma, COPD, or asthma + COPD. The relationship with exacerbations is stronger in COPD only than in asthma. TRAIL REGISTRATION: clinicaltrials.gov identifier: NCT02760329 (www.clinicaltrials.gov).

Relationships between symptoms and lung function in asthma and/or chronic obstructive pulmonary disease in a study performed in a real-life setting: the NOVELTY studyBackground: Asthma and chronic obstructive pulmonary disease (COPD) have many symptoms in common. To confirm diagnosis, doctors use spirometry, a test to measure the amount of air that can be breathed out from the lungs and how fast it can be blown out. The relationship between these measurements and symptoms in asthma and COPD is not well understood.Objectives: The aim of this research is to describe the characteristics, treatment, and impact of asthma and/or COPD in patients who are receiving their usual medical care.Methods: NOVELTY is a large study of around 12,000 patients across 19 countries. This analysis of NOVELTY looked at the relationships between two spirometry measurements and the symptoms of asthma and/or COPD experienced by patients. The spirometry measurements were: - forced expiratory volume in 1 second (FEV₁) ­ the amount of air that can be blown out of the lungs in 1 second- forced vital capacity (FVC) ­ the amount of air that can be forcibly breathed out from the lungs after taking the deepest breath possibleResults: The lower the FEV₁ and FVC, the more common the symptoms of breathlessness, wheeze attacks, night-time awakening, and coughing up of phlegm or mucus. These relationships were similar for FEV₁ and FVC. Lower FEV₁ was more strongly associated with worse symptoms in COPD than in asthma.Conclusion: These findings help to improve our understanding of the relationships between spirometry measures and symptoms in patients with asthma and/or COPD.

The many faces of COPD in real life: a longitudinal analysis of the NOVELTY cohort.

Background: The diagnosis of COPD requires the demonstration of non-fully reversible airflow limitation by spirometry in the appropriate clinical context. Yet, there are patients with symptoms and relevant exposures suggestive of COPD with either normal spirometry (pre-COPD) or preserved ratio but impaired spirometry (PRISm). Their prevalence, clinical characteristics and associated outcomes in a real-life setting are unclear. Methods: To investigate them, we studied 3183 patients diagnosed with COPD by their attending physician included in the NOVELTY study (clinicaltrials.gov identifier NCT02760329), a global, 3-year, observational, real-life cohort that included patients recruited from both primary and specialist care clinics in 18 countries. Results: We found that 1) approximately a quarter of patients diagnosed with (and treated for) COPD in real life did not fulfil the spirometric diagnostic criteria recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), and could be instead categorised as pre-COPD (13%) or PRISm (14%); 2) disease burden (symptoms and exacerbations) was highest in GOLD 3-4 patients (exacerbations per person-year (PPY) 0.82) and lower but similar in those in GOLD 1-2, pre-COPD and PRISm (exacerbations range 0.27-0.43 PPY); 3) lung function decline was highest in pre-COPD and GOLD 1-2, and much less pronounced in PRISm and GOLD 3-4; 4) PRISm and pre-COPD were not stable diagnostic categories and change substantially over time; and 5) all-cause mortality was highest in GOLD 3-4, lowest in pre-COPD, and intermediate and similar in GOLD 1-2 and PRISm. Conclusions: Patients diagnosed COPD in a real-life clinical setting present great diversity in symptom burden, progression and survival, warranting medical attention.

Prevalence, Diagnostic Utility and Associated Characteristics of Bronchodilator Responsiveness.

Rationale: The prevalence and diagnostic utility of bronchodilator responsiveness (BDR) in a real-life setting is unclear. Objective: To explore this uncertainty in patients aged ⩾12 years with physician-assigned diagnoses of asthma, asthma and chronic obstructive pulmonary disease (COPD), or COPD in NOVELTY, a prospective cohort study in primary and secondary care in 18 countries. Methods: The proportion of patients with a positive BDR test in each diagnostic category was calculated using 2005 (ΔFEV1 or ΔFVC ⩾12% and ⩾200 ml) and 2021 (ΔFEV1 or ΔFVC >10% predicted) European Respiratory Society/American Thoracic Society criteria. Measurements and Main Results: We studied 3,519 patients with a physician-assigned diagnosis of asthma, 833 with a diagnosis of asthma + COPD, and 2,436 with a diagnosis of COPD. The prevalence of BDR was 19.7% (asthma), 29.6% (asthma + COPD), and 24.7% (COPD) using 2005 criteria and 18.1%, 23.3%, and 18.0%, respectively, using 2021 criteria. Using 2021 criteria in patients diagnosed with asthma, BDR was associated with higher fractional exhaled nitric oxide; lower lung function; higher symptom burden; more frequent hospital admissions; and greater use of triple therapy, oral corticosteroids, or biologics. In patients diagnosed with COPD, BDR (2021) was associated with lower lung function and higher symptom burden. Conclusions: BDR prevalence in patients with chronic airway diseases receiving treatment ranges from 18% to 30%, being modestly lower with the 2021 than with the 2005 European Respiratory Society/American Thoracic Society criteria, and it is associated with lower lung function and greater symptom burden. These observations question the validity of BDR as a key diagnostic tool for asthma managed in clinical practice or as a standard inclusion criterion for clinical trials of asthma and instead suggest that BDR be considered a treatable trait for chronic airway disease.

Persistence of SARS-CoV-2 RNA shedding and infectivity in immunized population: Prospective study along different epidemiological periods in Argentina.

During the pandemic of COVID-19, numerous waves of infections affected the two hemispheres with different impacts on each country. Throughout these waves, and with the emergence of new variants, health systems and scientists have tried to provide real-time responses to the complex biology of SARS-CoV-2, dealing with different clinical presentations, biological characteristics, and clinical impact of these variants. In this context, knowing the extent period in which an infected individual releases infectious viral particles has important implications for public health. This work aimed to investigate viral RNA shedding and infectivity of SARS-CoV-2 beyond 10 days after symptom onset (SO). A prospective multicenter study was performed between July/2021 and February/2022 on 116 immunized strategic personnel with COVID-19 diagnosed by RT-qPCR, with asymptomatic (7%), mild (91%) or moderate disease (2%). At the time of diagnosis, 70% had 2 doses of vaccines, 26% had 2 plus a booster, and 4% had one dose. After day 10 from SO, sequential nasopharyngeal swabs were taken to perform RT-qPCR, viral isolation, and S gene sequencing when possible. Viral sequences were obtained in 98 samples: 43% were Delta, 16% Lambda, 15% Gamma, 25% Omicron (BA.1) and 1% Non-VOC/VOI, in accordance with the main circulating variants at each moment. SARS-CoV-2 RNA was detected 10 days post SO in 57% of the subjects. Omicron was significantly less persistent. Noteworthy, infective viruses could not be isolated in any of the samples. In conclusion, a 10-days isolation period was useful to prevent further infections, and proved valid for the variants studied. Recently, even shorter periods have been applied, as the Omicron variant is prevalent, and worldwide population is largely vaccinated. In the future, facing the possible emergence of new variants and considering immunological status, a return to 10 days may be necessary.

Breaking the vicious circle-the Asthma Referral Identifier (ReferID) tool.

Asthma is associated with a significant burden of disease, especially for patients with severe or uncontrolled asthma. Many patients with severe asthma still receive treatment in primary care settings and despite the availability of effective options, inadequate asthma treatment remains a concern, particularly the use of systemic corticosteroids to treat exacerbations and severe asthma. Around the world, many patients are stuck in a vicious circle of misdiagnosis, undertreatment, and poor understanding of disease severity and management. In this manuscript, we describe the development of The Asthma Referral Identifier (ReferID) tool, a simple, 4-item questionnaire that healthcare providers can use to help identify patients with uncontrolled and/or potentially severe asthma. ReferID was developed specifically for use in primary care clinics in low- and middle-income countries and other clinics, where the optimisation of asthma assessments and treatment recommended for countries with well-established healthcare systems, are not possible. ReferID was developed through an informal collaborative process involving international asthma experts as well as general practitioners, nurses, and specialists throughout the Asia Pacific, Latin America and Middle East regions, in conjunction with current evidence and treatment guidelines. In collaboration with local and regional partners around the world, the developers have adapted ReferID and translated it into 21 languages, and implementation is ongoing in 30 countries. ReferID has the potential to help break the vicious circle, improving disease outcomes and health-related quality of life for patients with asthma.

Superposición Asma-EPOC: los hallazgos en el estudio EPOC AR / Asthma-COPD Overlap: Findings of the EPOC AR Study

Introducción: Asma y EPOC son enfermedades heterogéneas, algunos pacientes comparten características clínicas de ambas. Existen incertidumbres en los criterios para definir superposición asma-EPOC (ACO) y la prevalencia es entre el 15% y el 25% de la población adulta con obstrucción crónica del flujo aéreo. Motiva este estudio determinar la prevalencia de ACO en Argentina, que es desconocida. Objetivos: Primario: Determinar prevalencia de ACO en el estudio EPOC-AR. Se cundarios: Evaluar y analizar las características clínicas de los pacientes con ACO, la gravedad de los síntomas, la frecuencia y gravedad de exacerbaciones. Describir y comparar el tratamiento entre ACO vs. EPOC puros. Base de datos del estudio EPOC.AR: Espirometrías, asma, atopía o rinitis, síntomas respiratorios: CAT (prueba de evaluación de EPOC) y mMRC (Medical Research Council modificado), frecuencia de exacerbaciones/año previo, comorbilidades y tratamientos. Guías GOLD 2017 para determinar grados de obstrucción espirométrica y Grupos A, B, C y D. Criterios diagnósticos de ACO (comité expertos USA, Europa del Este y Asia-Denver 2015): CRITERIOS MAYORES: 1. Obstrucción persistente (FEV1/FVC pos-BD <70% o LIN) en ≥ 40 años. 2. TBQ ≥ 10 paquetes/año, contaminación ambiental o biomasa. 3. Historia documentada de asma antes de los 40 años o respuesta pos-BD ≥ 400 mL en FEV1. CRITERIOS MENORES: 1. Historia documentada de atopía o rinitis alérgica. 2. Res puesta pos-BD en FEV1 > 200 mL. 3. Recuento de eosinófilos en sangre periférica ≥ 300 células-Ul-1 (no realizado en EPOC.AR). Prueba de Chi-cuadrado, Chi-cuadrado de Pearson, razón de verosimilitud, asociación lineal por lineal. Resultados: EPOC (n498), n95 con criterios de ACO, masculino (53,4%) y edad pro medio 63,6 años. El 1%, sin asma y respuesta BD ≥ 400 mL; el 32,7%, asmáticos (3,6% respuesta BD ≥ 400 mL y el 14,5%, entre 200-400 mL); n23 respuesta BD ≥ 400 mL (4,6%). Prevalen cia ACO: 19,08% (IC 15,6-22,5) y del 2,6% del total de la población de EPOC.AR. En población ACO vs. EPOC, se detectó: menor promedio de edad y de FEV1 pre BD (p < 0,01), mayor respuesta BD (p < 0,05), mayor frecuencia de sibilancias (p < 0,01; IC 2,75-7,64), mayor frecuencia de diagnóstico previo de asma (p < 0,01; IC 3,79-10,05) y el 26,08% tenían antecedentes familiares de asma. Mayor uso de ATB (p < 0,05) e ICS/LABA (p < 0,05; IC 1,1-5,3). Mayor frecuencia de exacerbaciones (12,47%; IC 9,56-15,39) que motivaron indicación de medicación en un 90,48% y 2,49 veces más de alteraciones en actividades diarias y ausentismo laboral. No se registraron diferencias significativas entre pacientes con ACO frente a EPOC puros en frecuencia de grupos A, B, C y D. Conclusiones: La prevalencia de ACO fue del 19,08% en pacientes EPOC del es tudio EPOC.AR; tenían significativamente menor edad, mayor grado de obstrucción, frecuencia de sibilancias, uso de antibióticos/año previo y CI (LABA/CI). Destacamos la importancia de identificar este fenotipo para un tratamiento adecuado por sus impli cancias clínicas, y deterioro en calidad de vida.

Background: Asthma and COPD are heterogeneous diseases, and some patients share clinical features of both conditions. There are uncertainties about the criteria to define asthma-COPD overlap (ACO), and its prevalence is 15-25% in the adult population with chronic airflow obstruction. The purpose of this study was to determine the prevalence of ACO in Argentina, which is unknown. Objectives: Primary: to determine the prevalence of ACO in the EPOC.AR study. Secondary: to evaluate and analyze the clinical features of patients with ACO, the severity of the symptoms, and the frequency and severity of exacerbations. to describe and compare the treatment of ACO with that of pure COPD. Database of the EPOC.AR study: spirometries, asthma, atopy or rhinitis, respiratory symptoms: CAT (COPD Assesment Test) and mMRC (Modified Medical Research Council) scale, frequency of exacerbations/previous year, comorbidities and treatments. 2017 GOLD Guides (Global Initiative for Chronic Obstructive Lung Disease) to determine airflow obstruction degrees and Groups A, B, C, and D. ACO diagnostic criteria (expert committee from USA, East Europe and Asia that took place in Denver, 2015): MAJOR CRITERIA: 1. Persistent obstruction (post-BD [bronchodilator] FEV1/FVC (forced expiratory volume in the first second/forced vital capacity) < 70% or LLN [lower limit of normal] ) in ≥ 40 years. 2. SM (smoking) ≥ 10 packs/year, air pollution or biomass. 3. Documented history of asthma before 40 years or post-BD response ≥ 400 ml in FEV1. MINOR CRITERIA: 1. Documented history of atopy or allergic rhinitis. 2. Post-BD response in FEV1 > 200 ml. 3. Peripheral blood eosinophil count ≥ 300 cells-Ul-1 (not performed in EPOC.AR). Chi-Square Test, Pearson's Chi Square Test, likelihood ratio, linear-by-linear association. Results: COPD (n 498), n 95 with ACO criteria, males (53.4%), mean age 63.6 years. 1% without asthma and BD response ≥ 400 ml; 32.7% asthmatics (3.6% with BD response ≥ 400 ml and 14.5% between 200-400 ml); n 23 with BD response ≥ 400 ml (4.6%). ACO prevalence: 19.08% (CI [Confidence Interval] 15.6-22.5) and 2.6% of the total population of EPOC.AR. In the comparison between the ACO and COPD populations, we detected the following: lower mean age and pre-BD FEV1 (p < 0.01), higher frequency of BD response (p < 0.05), higher frequency of sibilance (p < 0.01; CI 2.75-7.64), higher frequency of previous asthma diagnosis (p < 0.01; CI 3.79-10.05); and 26.08% had family history of asthma. Greater use of ATBs (antibiotics) (p < 0.05) and ICS (inhaled corticosteroids)/ LABA (long-acting beta- adrenergic agonists) (p < 0.05; CI 1.1-5.3). Higher frequency of exacerbations (12.47%; CI 9.56-15.39) that motivated the indication of medication in 90.48% and 2.49 times more alterations in daily activities and absence from work. There weren't any significant differences between patients with ACO and pure COPD regarding frequency of groups A, B, C and D. Conclusions: the prevalence of ACO was 19.08% in the COPD patients of the EPOC. AR study; they were significantly younger, with higher degree of obstruction, frequency of sibilance, use of antibiotics/previous year and inhaled corticosteroids (LABA/IC). We emphasize the importance of identifying this phenotype in order to use a suitable treat ment, given its clinical implications and deterioration in quality of life.

Asthma-COPD Overlap: Findings of the EPOC.AR Study / Superposición Asma-EPOC: los hallazgos en el estudio EPOC AR

ABSTRACT Background: Asthma and COPD are heterogeneous diseases, and some patients share clinical features of both conditions. There are uncertainties about the criteria to define asthma-COPD overlap (ACO), and its prevalence is 15-25% in the adult population with chronic airflow obstruction. The purpose of this study was to determine the prevalence of ACO in Argentina, which is unknown. Objectives: Primary: to determine the prevalence of ACO in the EPOC.AR study. Secondary: to evaluate and analyze the clinical features of patients with ACO, the severity of the symptoms, and the frequency and severity of exacerbations. to describe and compare the treatment of ACO with that of pure COPD. Database of the EPOC.AR study: spirometries, asthma, atopy or rhinitis, respiratory symptoms: CAT (COPD Assesment Test) and mMRC (Modified Medical Research Council) scale, frequency of exacerbations/previous year, comorbidities and treatments. 2017 GOLD Guides (Global Initiative for Chronic Obstructive Lung Disease) to determine airflow obstruction degrees and Groups A, B, C, and D. ACO diagnostic criteria (expert committee from USA, East Europe and Asia that took place in Denver, 2015): MAJOR CRITERIA: 1. Persistent obstruction (post-BD [bronchodilator] FEV1/FVC (forced expiratory volume in the first second/forced vital capacity) < 70% or LLN [lower limit of normal] ) in ≥ 40 years. 2. SM (smoking) ≥ 10 packs/year, air pollution or biomass. 3. Documented history of asthma before 40 years or post-BD response ≥ 400 ml in FEV1. MINOR CRITERIA: 1. Documented history of atopy or allergic rhinitis. 2. Post-BD response in FEV1 > 200 ml. 3. Peripheral blood eosinophil count ≥ 300 cells-Ul-1 (not performed in EPOC.AR). Chi-Square Test, Pearson's Chi Square Test, likelihood ratio, linear-by-linear association. Results: COPD (n 498), n 95 with ACO criteria, males (53.4%), mean age 63.6 years. 1% without asthma and BD response ≥ 400 ml; 32.7% asthmatics (3.6% with BD response ≥ 400 ml and 14.5% between 200-400 ml); n 23 with BD response ≥ 400 ml (4.6%). ACO prevalence: 19.08% (CI [Confidence Interval] 15.6-22.5) and 2.6% of the total population of EPOC.AR. In the comparison between the ACO and COPD populations, we detected the following: lower mean age and pre-BD FEV1 (p < 0.01), higher frequency of BD response (p < 0.05), higher frequency of sibilance (p < 0.01; CI 2.75-7.64), higher frequency of previous asthma diagnosis (p < 0.01; CI 3.79-10.05); and 26.08% had family history of asthma. Greater use of ATBs (antibiotics) (p < 0.05) and ICS (inhaled corticosteroids)/ LABA (long-acting beta- adrenergic agonists) (p < 0.05; CI 1.1-5.3). Higher frequency of exacerbations (12.47%; CI 9.56-15.39) that motivated the indication of medication in 90.48% and 2.49 times more alterations in daily activities and absence from work. There weren't any significant differences between patients with ACO and pure COPD regarding frequency of groups A, B, C and D. Conclusions: the prevalence of ACO was 19.08% in the COPD patients of the EPOC. AR study; they were significantly younger, with higher degree of obstruction, frequency of sibilance, use of antibiotics/previous year and inhaled corticosteroids (LABA/IC). We emphasize the importance of identifying this phenotype in order to use a suitable treat ment, given its clinical implications and deterioration in quality of life.

RESUMEN Introducción: Asma y EPOC son enfermedades heterogéneas, algunos pacientes comparten características clínicas de ambas. Existen incertidumbres en los criterios para definir superposición asma-EPOC (ACO) y la prevalencia es entre el 15% y el 25% de la población adulta con obstrucción crónica del flujo aéreo. Motiva este estudio determinar la prevalencia de ACO en Argentina, que es desconocida. Objetivos: Primario: Determinar prevalencia de ACO en el estudio EPOC-AR. Se cundarios: Evaluar y analizar las características clínicas de los pacientes con ACO, la gravedad de los síntomas, la frecuencia y gravedad de exacerbaciones. Describir y comparar el tratamiento entre ACO vs. EPOC puros. Base de datos del estudio EPOC.AR: Espirometrías, asma, atopía o rinitis, síntomas respiratorios: CAT (prueba de evaluación de EPOC) y mMRC (Medical Research Council modificado), frecuencia de exacerbaciones/año previo, comorbilidades y tratamientos. Guías GOLD 2017 para determinar grados de obstrucción espirométrica y Grupos A, B, C y D. Criterios diagnósticos de ACO (comité expertos USA, Europa del Este y Asia-Denver 2015): CRITERIOS MAYORES: 1. Obstrucción persistente (FEV1/FVC pos-BD <70% o LIN) en ≥ 40 años. 2. TBQ ≥ 10 paquetes/año, contaminación ambiental o biomasa. 3. Historia documentada de asma antes de los 40 años o respuesta pos-BD ≥ 400 mL en FEV1. CRITERIOS MENORES: 1. Historia documentada de atopía o rinitis alérgica. 2. Respu esta pos-BD en FEV1 > 200 mL. 3. Recuento de eosinófilos en sangre periférica ≥ 300 células-Ul-1 (no realizado en EPOC.AR). Prueba de Chi-cuadrado, Chi-cuadrado de Pearson, razón de verosimilitud, asociación lineal por lineal. Resultados: EPOC (n498), n95 con criterios de ACO, masculino (53,4%) y edad pro medio 63,6 años. El 1%, sin asma y respuesta BD ≥ 400 mL; el 32,7%, asmáticos (3,6% respuesta BD ≥ 400 mL y el 14,5%, entre 200-400 mL); n23 respuesta BD ≥ 400 mL (4,6%). Prevalen cia ACO: 19,08% (IC 15,6-22,5) y del 2,6% del total de la población de EPOC.AR. En población ACO vs. EPOC, se detectó: menor promedio de edad y de FEV1 pre BD (p < 0,01), mayor respuesta BD (p < 0,05), mayor frecuencia de sibilancias (p < 0,01; IC 2,75-7,64), mayor frecuencia de diagnóstico previo de asma (p < 0,01; IC 3,79-10,05) y el 26,08% tenían antecedentes familiares de asma. Mayor uso de ATB (p < 0,05) e ICS/LABA (p < 0,05; IC 1,1-5,3). Mayor frecuencia de exacerbaciones (12,47%; IC 9,56-15,39) que motivaron indicación de medicación en un 90,48% y 2,49 veces más de alteraciones en actividades diarias y ausentismo laboral. No se registraron diferencias significativas entre pacientes con ACO frente a EPOC puros en frecuencia de grupos A, B, C y D. Conclusiones: La prevalencia de ACO fue del 19,08% en pacientes EPOC del es tudio EPOC.AR; tenían significativamente menor edad, mayor grado de obstrucción, frecuencia de sibilancias, uso de antibióticos/año previo y CI (LABA/CI). Destacamos la importancia de identificar este fenotipo para un tratamiento adecuado por sus impli cancias clínicas, y deterioro en calidad de vida.

Prevalence of COPD in 6 Urban Clusters in Argentina: The EPOC.AR Study. / Prevalencia de enfermedad pulmonar obstructiva crónica en 6 aglomerados urbanos de Argentina: el estudio EPOC.AR.

INTRODUCTION: The prevalence of chronic obstructive pulmonary disease (COPD) has not been studied in Argentina. OBJECTIVES: To determine the prevalence and relevant clinical characteristics of COPD in a representative sample. MATERIAL AND METHODS: We performed a cross-sectional study in a population of adults aged ≥ 40 years randomly selected by cluster sampling in 6 urban locations. Subjects answered a structured survey and performed pre- and post-bronchodilator spirometry (PBD). COPD was defined as FEV1/FVC ratio < 0.7 predicted value. The total prevalence was estimated for each cluster with its 95% confidence interval (CI). RESULTS: Of 4,599 surveys and 3,999 spirometries, 3,469 were considered of adequate quality (86.8%) for our study. The prevalence of COPD was 14.5% (CI: 13.4-15.7). The distribution of COPD cases according to FEV1 (GOLD 2017) was stage 1: 38% (CI: 34-43); stage 2: 52% (CI: 47-56); stage 3: 10% (CI: 7-13); and stage 4: 1% (CI: 0-2), and according to the refined ABCD (GOLD 2017) assessment: A: 52% (CI: 47-56); B: 43% (CI: 39-48); C: 1% (CI: 0-2); D: 4% (CI: 2-6). The rate of underdiagnosis was 77.4% (CI 73.7-81.1%) and diagnostic error 60.7% (CI 55.1-66.3%). A significant association was found between COPD and age (OR 3.77 in individuals 50-59 years of age and 19.23 in those > 80 years), male gender (OR 1.62; CI 1.31-2), smoking (OR 1.95; CI 1.49-2.54), low socioeconomic status (OR 1.33; CI 1.02-1.73), and previous tuberculosis (OR 3.3; CI 1.43-7.62). CONCLUSIONS: We estimate that more than 2.3 million Argentineans have COPD, with high rates of underdiagnosis and diagnostic error.

INSTEAD: a randomised switch trial of indacaterol versus salmeterol/fluticasone in moderate COPD.

The Indacaterol: Switching Non-exacerbating Patients with Moderate COPD From Salmeterol/Fluticasone to Indacaterol (INSTEAD) study investigated the effect of switching patients at low risk of chronic obstructive pulmonary disease (COPD) exacerbations from salmeterol/fluticasone (SFC; inhaled corticosteroid (ICS) regimen) to indacaterol monotherapy (non-ICS regimen). This 26-week, double-blind, double-dummy, parallel-group, phase IV study, randomised 581 patients with moderate COPD to indacaterol 150 µg once daily or SFC 50/500 µg twice daily. Patients had been receiving SFC 50/500 µg for ≥3 months, with no COPD exacerbations for more than a year before the study (patients for whom ICS is not recommended). The primary objective was to demonstrate non-inferiority of indacaterol to SFC, measured by trough forced expiratory volume in 1 second (FEV1) after 12 weeks (non-inferiority margin of 0.06 L). The primary objective was met, with a mean treatment difference of 9 mL (95% CI -45-26 mL). There were no significant differences between treatments in terms of breathlessness (transition dyspnoea index) or health status (Saint George's Respiratory Questionnaire) at weeks 12 or 26, or rescue medication use or COPD exacerbation rates over 26 weeks. Safety profiles of both treatments were as expected. This study demonstrated that patients with moderate COPD and no exacerbations in the previous year can be switched from SFC to indacaterol 150 µg with no efficacy loss.